Quality System Compliance Specialist

At PDC by Brady, our commitment to quality extends beyond our products to include every facet of our operations. The QMS Compliance Specialist plays a key role in ensuring that our quality systems and processes adhere to the highest standards, ensuring regulatory compliance and supporting the overall pursuit of excellence across the organization. This position involves collaboration with multiple departments, including Engineering, Manufacturing, Regulatory Affairs, and Marketing, to ensure continuous improvement and compliance with industry regulations.

• Lead the development, implementation, and maintenance of quality systems, ensuring alignment with ISO 9001, ISO 13485, ISO 14971, and FDA regulations.
• Take ownership of document control systems, including user account management, document workflow optimization, and auditing, while supporting system proficiency for platforms like Smartsheets, ETQ, and SAP.
• Manage and update quality-related documentation such as Standard Operating Procedures (SOPs), Quality Manual, Quality Policies, and related procedures, ensuring compliance with applicable medical device regulations.
• Support New Product Development (NPD) projects, ensuring regulatory research is conducted and all necessary documentation (product registrations, certifications, and reports) is completed in compliance with environmental and regulatory standards.
• Manage FDA Recall and Medical Device Reporting (MDR) procedures, maintaining timely facility registrations and device listings.
• Assist with regulatory compliance for medical devices, cosmetics, and chemicals, including customer compliance requests, UDI labeling, and regulatory submissions (e.g., 510(k) submissions, eSubmitter).
• Oversee the maintenance of FDA facility registrations and the management of accounts in platforms like GS1 US, FURL, and Webtrader.
• Work closely with subject matter experts across departments to define product and material specifications, aligning with quality objectives and ensuring compliance.
• Actively participate in continuous improvement projects, identifying opportunities to streamline quality processes and enhance system efficiency.
• Collaborate with teams across Engineering, Manufacturing, Regulatory Affairs, and Marketing to achieve shared quality goals and ensure the smooth launch of new products.
• Analyze quality data to identify trends and areas for improvement, and proactively address critical business issues that impact profitability.
• Use data-driven insights to inform and support the development of quality initiatives that align with the company’s objectives.
• Support customer compliance requests for medical devices, cosmetics, and other products, including advising on ISO certifications and chemical compliance (e.g., CA Prop 65, EU REACH, and RoHS).
• Ensure all regulatory platforms (e.g., GS1, FURL, eSubmitter) are up-to-date, ensuring smooth compliance operations.